The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2186-2013·Announced 2013-09-18

Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water

The FDA is recalling Monoject 100 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or those with hospitalization reports, are rated as Severe (4). While specific injury reports are not detailed in the provided text, the potential for non-sterile water in IV devices poses a significant risk of infection, aligning with the Severe classification for Class II medical device recalls with potential for serious harm.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Monoject 100 Units/mL Heparin Lock Flush syringes (12 mL syringe with 5 mL fill) manufactured by Covidien LLC. The recall is due to the possibility that the syringes contain non-sterile water, despite being labeled as saline or heparin. These sterile, single-use products are intended for flushing and locking compatible intravenous administration sets and indwelling intravenous access devices.

The affected product is identified by Product ID 8881590125 and includes Lot Numbers 13A0084N and 13D0824N. A total of 330,120 units were distributed nationwide in the United States and in Bermuda. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare facilities and consumers should stop using the affected syringes immediately. Users should check their inventory for the specific lot numbers listed above. If the product has been used, healthcare providers should monitor patients for any signs of infection or adverse reactions and report any issues to the FDA or the manufacturer.

The recalled product

Product
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
Manufacturer
Covidien LLC
Category
Medical Device — Syringes
Hazard
Affected units
330,120

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 13A0084N 13D0824N

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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